Hepatic Steatosis and Fibrosis in Rheumatoid Arthritis Patients

April 11, 2023 updated by: Amr Hamed, Sohag University

Evaluation of Hepatic Steatosis and Fibrosis in Rheumatoid Arthritis Patients: a Cross-sectional Case-control Study

studying the prevalence of hepatic steatosis and fibrosis in a large scale of patients with RA and healthy controls

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The outpatient clinic of the Rheumatology Department in Sohag University

Description

Inclusion Criteria:

  1. RA according to the American College of Rheumatology (ACR)/EULAR 2010 criteria (Aletaha et al., 2010)
  2. Age≥18 years

Exclusion Criteria:

  • History of hepatitis B and C virus infection.
  • Receiving hepatotoxic drugs other than RA-specific drugs.
  • Alcohol abuse (i30 g/day in men and ⩾20 g/day in women).
  • Diagnosis of Wilson's disease, α1-antitrypsin deficiency or hemochromatosis.
  • Autoimmune liver disease.
  • Cancer.
  • Pregnancy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
control
Diagnostic test: ultrasonography
studying degree of steatosis
Rheumatoid arthritis patients
Diagnostic test: ultrasonography
studying degree of steatosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
degree of hepatic steatosis
Time Frame: 1 day during examination
degree of hepatic steatosis by ultrasonography and Hepatic Steatosis Index.
1 day during examination
degree of hepatic fibrosis
Time Frame: 1 day during examination
degree of hepatic fibrosis by FIB-4 and APRI tests
1 day during examination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2023

Primary Completion (Anticipated)

August 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

December 25, 2022

First Submitted That Met QC Criteria

January 10, 2023

First Posted (Actual)

January 11, 2023

Study Record Updates

Last Update Posted (Actual)

April 12, 2023

Last Update Submitted That Met QC Criteria

April 11, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-22-11-17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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